The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Urine Collection Products Modification.
| Device ID | K940206 |
| 510k Number | K940206 |
| Device Name: | BARD URINE COLLECTION PRODUCTS MODIFICATION |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | J. Teresa Dorriety |
| Correspondent | J. Teresa Dorriety C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-14 |
| Decision Date | 1994-09-16 |